Regulations.gov document

Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2)…

Notice · FDA-2017-D-5974 · posted May 10, 2019

Key facts

Document ID FDA-2017-D-5974-0010
Title Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application; Guidance for Industry; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2017-D-5974
Posted May 10, 2019
Federal Register citation 84 FR 20637
FR document number 2019-09662
Comment period opens May 10, 2019
Effective date May 10, 2019

At a glance

  • 1–9 Pages
  • 1–9 Public comments on this docket

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Regulations.gov documents

Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.

Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date:

Browse all Regulations.gov documents